It is known in the biopharmaceutical field to provide and make use of receptacles able to receive a biopharmaceutical product that is generally liquid or pasty at least when it is to be mixed, as its content. Such receptacles are typically intended for the preparation of a biopharmaceutical product, for storage, for transport, or for carrying out a specific process that is physical, chemical, or biological in nature, for example a freezing/thawing process.
“Biopharmaceutical product” is understood here to mean a product obtained from biotechnology (culture media, cell cultures, buffer solutions, artificial nutrition liquids), or a pharmaceutical product, or more generally a product intended for use in the medical field.
Such a receptacle for biopharmaceutical use firstly comprises a flexible container having a flexible wall delimiting at the front an inside space for receiving the biopharmaceutical product. Such a flexible container or bag is disposable, closed, sealed, sterile, and of plastic material such as polyethylene or a complex including polyethylene. Such a container comprises means for introducing into and means for extracting from the inside space the biopharmaceutical product or components of the product, it being possible to place these means, depending on the moment and on requirements, in the open or closed state.
There are known bags of this type in which the two large walls are directly joined to each other. Once expanded, such bags have a limited volume and remain relatively thin, which is why they are often referred to as “pillow bags” or “2D bags” (where D stands for dimensional). Also known are 3D bags which have two large walls connected by and welded to two side gussets, which can be folded flat or unfolded when deployed, the volume then reaching at least 50 liters and up to 3000 liters or more. Such 3D bags are described in document WO00/04131a or sold under the trademark FLEXEL® 3D.
Such a receptacle for biopharmaceutical use secondly comprises mixing means which mix the content of the inside space. These mixing means are adjacent to a defined local part of the flexible wall, for example but not limited to the bottom wall or the top wall. These mixing means include movable displacement means, which are adjoining the inside space and are able to displace the content within it.
Such a receptacle for biopharmaceutical use comprises, thirdly, means for driving the movable displacement means, and fourthly, rigid and leaktight connection means ensuring a rigid and leaktight connection between the mixing means and the given part of the flexible wall.
The prior art is illustrated in particular by patents WO 02/062458, WO 03/028869, WO 2006/002091, WO 2006/0630a87 and WO 2009/143925.
In the known embodiments, the movable displacement means of the mixing means are typically a propeller rotatably mounted within the inside space itself. As a result, these known embodiments have the disadvantages inherent in the presence within the inside space of movable displacement means such as a rotating fan. These disadvantages include the space required and the risk of damaging the flexible wall. Another disadvantage arises when the mixture concerns a content that is to undergo a freezing/thawing sequence, because such mixing means cannot be caught within the solidified content.
The invention aims to provide a solution to these disadvantages by proposing mixing means based on a completely different concept.
There are known studies which seek to apply the water-jet propulsion process of squids and jellyfish to industry. This involves generating a jet stream which can be efficiently used to set an adjacent fluid in motion. To achieve this, a casing is provided which defines an inside chamber and has an opening. A flexible membrane is mounted in the casing and, by its movements, it modifies the volume of the chamber. Eddies are thus ejected from the chamber through the opening. U.S. Pat. No. 5,894,990, U.S. Pat. No. 6,123,145, U.S. Pat. No. 6,457,654, U.S. Pat. No. 5,988,522, U.S. Pat. No. 6,056,204, U.S. Pat. No. 5,957,413 and U.S. Pat. No. 5,758,823 refer to this technology. This technology has been suggested for various applications, such as motors and aeronautics, but not in the field of receptacles for biopharmaceutical use in which the flexible container has a flexible wall. The existence of such a flexible wall further discourages the application of this technology in this field, because the flexible wall does not allow setting the mixing means in motion.
The invention aims to solve these problems.